The present invention relates to implantable materials for replacement of fibrous or cartilaginous tissue. More particularly, the present invention relates to a method of making hydrophilic polymeric implants having controlled pore size which can be shaped and used to replace fibrous or cartilaginous tissue in animals and man.
For many years people have been searching for materials useful as replacements for different types of tissue. Materials tried include silicones, acrylates and other plastics, and meals. While each of these materials has certain advantages, some problems have developed in use. For example, silicone becomes hardened and displaced over time so its use as a breast augmentation implant, while tried often in the 1960's, has declined. Similarly, although metals and some plastic materials have been used for joints and other bone replacements, rejection problems have limited the use to those with no other alternatives. Plastics have also been tried as both soft and hard tissue replacements but there have been similar problems.
Because of these problems with the materials tried to date, a great deal of attention has been focused on modified plastics, particularly the acrylates and methacrylates, for implantation. Because of their transparent nature and easy moldability, there has been special emphasis on the dental and optical uses of the acrylate family. The optical uses have included scleral buckles and lens replacements while the dental area has focused on tooth and alveolar ridge replacement. In addition, some work has been done on breast or soft tissue replacement using acrylates and methacrylates. The acrylates and methacrylates, when implanted in a porous form, show tissue ingrowth and/or calcification which may support or harden the implant; in many cases, this ingrowth or calcification has been a problem.
The Kroder et al. U.S. Pat. No. 3,628,248 is an example of the uses tried for the acrylates and methacrylates. This patent discloses a proCess for forming artificial implants, preferably for dental uses, using a variety of plastics, most preferably the acrylates and methacrylates. Kroder attempts to encourage tissue growth into the material using a porous surface. They obtain a porous surface by mixing potassium chloride in the acrylate monomer before polymerization. The potassium chloride is then leached out of the outer surface, leaving pores. However, the initiator used by Kroder as a hydrophobic could cause problems with tissue rejection. The use of hydrophobic plastics such as that shown by Kroder could also produce problems with rejection since there cannot be any transfer of electrolytes across the implant.
U.S. Pat. No. 4,199,864, issued on application by Ashman, attempted to cure the problems with the Kroder material. Ashman used polymethyl methacrylate as a dental implant material, and tried to form a porous surface by mixing a salt with the hydrophobic material. In fact, Ashman also lined the mold before polymerization with the salt crystals to provide surface porosity. Ashman found that even doing this, a "skin" formed over the plastic so it was necessary to grind off the outer layer of the material to expose the crystals. After exposure, Ashman let the material soak in water in an attempt to leach the salt crystals out. However, this just removed the salt from the outer layer because of the hydrophobicity of the material. Again, the hydrophobic material itself could still cause rejection problems.
In U.S. Pat. No. 4,536,158, issued to Bruins and Ashman and assigned to the same assignee as the Ashman patent, the same polymethyl methacrylate material was used for a dental implant. In this patent, the hydrophobic material was coated with a small amount of a hydrophilic methacrylate, hydroxyethyl methacrylate (HEMA) in an attempt to reduce rejection. The Bruins et al. patent describes using the material for replacing bone for dental applications. Very small particles of the coated hydrophobic material is made into a porous filler by packing the particles so that pseudopores are formed between the individual particles. While this approach is fine for a nonweight bearing application, its overall usefulness is limited. This material is sold commercially by Medical Biological Sciences, Inc., under the trade name HTR.
Others have used acrylates in various ways in order to replace bone or fibrous tissue. For example, U.S. Pat. Nos. 3,609,867 and 3,789,029, both issued to Hodash, concern an acrylate/ground bone mixture while U.S. Pat. No. 3,713,860, issued to Aushern, discloses a mixture of a porous aluminum oxide and a methyl methacrylate polymer to form a bone replacement substitute.
None of these bone or fibrous tissue substitutes have solved all the problems with rejection and controlled ingrowth. Accordingly, HEMA has been one of the newer materials tried for a variety of implantation and surgical uses. For example, in U.S. Pat. No. 4,452,776, issued on an application of Refojo, HEMA is used not only as a replacement for acrylates for contact lenses but also as a scleral buckle. HEMA has also been used as a breast augmentation material and as a dental implant. See Kronman et al., "poly-HEMA Sponge: A Biocompatible Calcification Implant", Biomat., Med. Dev., Art. Org., 7(2):299-305 (1979). HEMA has been used as an implant material in both a porous and nonporous state. However, the only method of obtaining porous HEMA has been to polymerize the hydroxyethyl methacrylate monomer about water molecules. For example, the Kronman et al. article discusses both 70/30 and 80/20% HEMA/water mixtures. polymerizing about water molecules forms micropores within the hydrophilic HEMA but it does not allow any way to control the pore size with accuracy. Further, there is no way of being sure that the pores range throughout the material.
Problems with uncontrolled pore size besides the question of whether the pores are evenly distributed throughout the material include the problem that the properties of HEMA after implantation are different depending upon pore size. For example, with a pore size of 60-150 .mu., calcification takes place, leading to a bone-like implant. If the pore size is between 225 to 275 .mu., the properties of the material after implantation are similar to those of cartilage while a pore size of 300 to 450 .mu. yields a fibrous-like tissue, similar to fibrous connective tissues.
Accordingly, an object of the invention is to provide a method making a material for forming implants of a biocompatible material which does not cause rejection and promotes ingrowth without calcification.
Another object of the invention is to provide a method of forming a biocompatible fibrous tissue replacement.
A further object of the invention is to provide a biocompatible and shapable cartilaginous implant material with a variety of uses, e.g., nasal augmentation, cartilage reshaping, and ear replacement.
A still further object of the invention is to provide a biocompatible synthetic replacement for fibrous, connective tissue which could be used for soft tissue augmentation, e.g., breast augmentation.
These and other objects and features of the invention will be apparent from the following description and the drawings.